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Fertility drug REKOVELLE® under the microscope in Real-World study

NCT ID NCT05499052

Knowledge-focused Sponsor: Ferring Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observed 201 women in Nordic countries and Switzerland who were using the fertility drug REKOVELLE® for the first time during IVF or ICSI. Researchers tracked how doctors prescribed the drug, including dose adjustments and use of a dosing app, to understand real-world patterns. The goal was to gather information on effectiveness and safety without changing standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

201 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women who are prescribed REKOVELLE® undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Females aged 18 years or older at enrolment * Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor * Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label * Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed Exclusion Criteria: * Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated * Women with a contraindication for prescription of REKOVELLE® treatment * Hypersensitivity to the active substance or to any of the excipients * Tumours of the hypothalamus or pituitary gland * Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome * Gynaecological haemorrhages of unknown aetiology * Ovarian, uterine, or mammary carcinoma * Primary ovarian failure * Malformations of sexual organs incompatible with pregnancy * Fibroid tumours of the uterus incompatible with pregnancy * Pregnancy and breast feeding * Women who undergo ovarian stimulation for fertility preservation * Women placed under judicial protection, guardianship, or supervision * Women who are considered as vulnerable population

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Controlled ovarian stimulation

Contacts and locations

Locations

  • Ferring Investigational Site

    Copenhagen, Denmark

  • Ferring Investigational Site

    Horsens, Denmark

  • Ferring Investigational Site

    Køge, Denmark

  • Ferring Investigational Site

    Odense, Denmark

  • Ferring Investigational Site

    Søborg, Denmark

  • Ferring Investigational Site

    Skien, Norway

  • Ferring Investigational Site

    Malmö, Sweden

  • Ferring Investigational Site

    Baden, Switzerland

  • Ferring Investigational Site

    Basel, Switzerland

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